phase 2b pivotal study of izokibep in non-infectious, intermediate-, posterior- or pan-uveitis

Conditions: Uveitis

Summary: izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17a, to which it binds with high affinity. this study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.


Eligibility criteria:
inclusion criteria: general * subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. * 18 years to 75 years of age type of subject and disease characteristics * subject is diagnosed with non-infectious intermediate-, posterior- or pan-uveitis * active disease defined by the presence of at least 1 of the following criteria in at least 1 eye despite treatment with stable doses of corticosteroids for at least 2 weeks prior to day 1: * active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by dilated indirect ophthalmoscopy, fundus photography, fluorescein angiography (fa), and spectral-domain optical coherence tomography (sd-oct) to determine whether a lesion is active or inactive (the central reading center assessment using fa, fundus photography and/or sd-oct is required to confirm eligibility prior to day 1). * ≥ 2+ vitreous haze (national eye institute \[nei\]/standardization of uveitis nomenclature \[sun\] criteria) by digital indirect ophthalmoscope and fundus photography (the central reading center assessment using fundus photography is required to confirm eligibility prior to day 1). * currently receiving treatment with oral corticosteroids (≥ 7.5 mg/day to ≤ 40 mg/day oral prednisone/prednisolone or corticosteroid equivalent) at a stable dose for at least 2 weeks prior to day 1. exclusion criteria: disease-related medical conditions * subject with isolated anterior uveitis * subject with serpiginous choroidopathy * subject with confirmed or suspected infectious uveitis * subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the study * subject with intraocular pressure of ≥ 25 mmhg while on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury * subject with severe vitreous haze that precludes visualization of the fundus prior to first dose of study drug * subject has a contraindication for mydriatic eye drops or subject cannot be dilated sufficiently well to permit good fundus visualization * subject with best corrected visual acuity (bcva) \< 20 letters (early treatment diabetic retinopathy study \[etdrs\]) in at least 1 eye prior to first dose of study drug * subject with proliferative or severe non-proliferative retinopathy or clinically significant macular edema due to diabetic retinopathy * subject with neovascular/wet age-related macular degeneration * subject with an abnormality of the vitreo-retinal interface with the potential for macular structural damage independent of the inflammatory process * subject with a history of active scleritis ≤ 12 months of first dose of study drug other protocol defined inclusion/exclusion criteria may apply

Keywords: non-infectious uveitis intermediate-uveitis posterior-uveitis pan-uveitis